ABC Trial: Awakening and Breathing Controlled
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00097630 |
|
Recruitment Status :
Completed
First Posted : November 25, 2004
Last Update Posted : December 11, 2009
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Aging Respiration, Artificial | Procedure: SAT: Spontaneous Awakening Trial Procedure: SBT: Spontaneous Breathing Trial | Not Applicable |
Unnecessary delays in removing patients from mechanical ventilation increase morbidity, mortality, and cost. According to recently published guidelines, the current standard of care for weaning involves the daily assessment of patients while they are breathing spontaneously, also known as spontaneous breathing trials (SBT). While there are important data to support a daily cessation of sedatives and analgesics to the point of patient awakening, the benefit of combining such a daily spontaneous awakening trial (SAT) and an SBT is not known.
This multi-center, randomized controlled trial will test whether a 2-step process of weaning that combines a daily awakening trial (achieved by stopping all sedatives and narcotics every morning) with a daily spontaneous breathing trial is superior to the current standard of care.
The number of days the patient is able to live off the ventilator is the primary question being studied. The secondary questions include the number of days the patient is in Intensive Care Unit (ICU) and the hospital, the complications associated with being on the ventilator (such as the duration and severity of delirium and coma), and in-hospital and one-year mortality. Also, cognitive, psychological, and functional/quality of life outcomes will be measured at discharge and 3 and 12 months later.
In addition, the study will measure plasma drug levels twice daily on five sequential days within 30 minutes of testing with highly reliable and well validated instruments to measure sedation level (i.e., RASS) and delirium (i.e. CAM-ICU).
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 334 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single |
| Primary Purpose: | Treatment |
| Official Title: | Cognitive Impairment in the ICU: Evaluation and Outcomes |
| Study Start Date : | October 2003 |
| Actual Primary Completion Date : | August 2007 |
| Actual Study Completion Date : | August 2007 |
- Ventilator free days
- Length of stay in the ICU and hospital
- 28-day and 1-year survival
- Duration of coma and delirium
- Cognitive function [ Time Frame: at discharge, 3 months, and 12 months ]
- Psychological status [ Time Frame: at discharge, 3 months, and 12 months ]
- Functional status [ Time Frame: at discharge, 3 months, and 12 months ]
- Quality of life [ Time Frame: at discharge, 3 months, and 12 months ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Recently on mechanical ventilation (less than 2 weeks prior to enrollment)
- Require mechanical ventilation for more than 12 hours
- Over 18 years old
- Under the services of medicine, cardiology, and neurology
Exclusion Criteria:
- Admission after cardiopulmonary arrest
- Inability to obtain informed consent
- Existence of an extubation order at the time of the evaluation
- Dependence upon mechanical ventilation for 2 weeks prior to enrollment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00097630
| United States, Illinois | |
| University of Chicago | |
| Chicago, Illinois, United States, 60637 | |
| United States, Pennsylvania | |
| Hospital of the University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| University of Pennsylvania - Presbyterian Medical Center | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Tennessee | |
| St. Thomas Hospital | |
| Nashville, Tennessee, United States, 37202 | |
| Principal Investigator: | E Wesley Ely, MD, MPH | Vanderbilt University Medical Center | |
| Study Director: | Brenda T Pun, RN, ACNP | Vanderbilt University Medical Center | |
| Principal Investigator: | Richard W Light, MD | St. Thomas Hospital |
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00097630 |
| Other Study ID Numbers: |
AG0011 5K23AG001023-04 ( U.S. NIH Grant/Contract ) |
| First Posted: | November 25, 2004 Key Record Dates |
| Last Update Posted: | December 11, 2009 |
| Last Verified: | August 2008 |
|
mechanical ventilation delirium sedation scoring cognitive impairment ventilation weaning |